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Dynavax stock surges 18% on hepatitis B vaccine approval

Dynavax Technologies Corporation DVAX, -3.84% shares surged 18% in premarket trade Friday after the company said its hepatitis B vaccine was approved by the Food and Drug Administration. The vaccine, Hepislav-B, is the first new hepatitis B vaccine in the U.S. in decades and consists of just two doses over a month, compared with current hepatitis B vaccines' three doses over six months. Dynavax expects to launch the vaccine in the first quarter of 2018, and said it has been building infrastructure and working on manufacturing processes to meet expected demand. The latest development marks the culmination of a prolonged roller-coaster ride for Dynavax, including two previous applications that the FDA failed to approve and a major corporate restructuring and significant layoffs undertaken by Dynavax. Moreover, despite previous expectations that the vaccine's label would include questions about cardiovascular risk, the label does not have such a warning; prescribing information only mentions cardiovascular incidents in its summary of clinical trial results. "Our read of the label looks like a best-case scenario, with no red flags around safety," said RBC Capital Markets analyst Matthew Eckler. "Given Hepislav's superior efficacy and convenience profile, we continue to see potential to grow the current hep B vaccine market (~$270 M) through increased compliance, premium pricing and the capture of adult diabetic population, resulting in $300M projected peak revenue." Hepatitis B can be a lifelong, chronic disease and lead to liver damage, liver cancer and death. Though it has no cure, treatment can help. Dynavax shares have surged 26.5% over the last three months, compared with a 6% rise in the S&P 500 SPX, -0.38% and a 7.4% rise in the Dow Jones Industrial Average DJIA, -0.43%